> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Mexitil Not Withdrawn Over Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/mexitil-not-withdrawn-over-safety-efficacy-fda/
- Published: 2019-10-31T12:00:00.000Z
- Updated: 2026-09-14T15:51:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145384

*Federal Register* notice: FDA has determined that Boehringer Ingelheim’s Mexitil (mexiletine hydrochloride) capsules, 150 mg, 200mg, and 250 mg, were not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference Mexitil if all other legal and regulatory requirements are met. Mexitil is indicated for treating documented ventricular arrhythmias, such as sustained ventricular tachycardia. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-23923.pdf?ref=fdaweb.com).